Quality Engineer - Medical Devices, CAPA & Compliance

LivaNova PLC; Arvada (CO); On-site; USD 67,500 - 82,500; Full time

Benefits offered by this job

Health benefits – Medical, Dental, Vision

Personal and Vacation Time

Retirement & Savings Plan (401K)

Employee Stock Purchase Plan

Training & Education Assistance

Bonus Referral Program

Service Awards

Employee Recognition Program

Flexible Work Schedules

Job summary

LivaNova PLC is seeking a Quality Engineer in Arvada, CO to ensure compliance with quality management systems in medical device manufacturing. The role involves analyzing nonconforming products, leading investigations, and enhancing production quality.

Qualified candidates should have a Bachelor's degree and experience in medical devices. Benefits include health insurance, a 401K plan, and flexible work schedules.

Qualifications

• Minimum 1–3 years in Class II/III medical device manufacturing.
• Knowledge of FDA, ISO 13485 regulatory requirements.
• Proficiency with quality tools.

Responsibilities

• Collect and analyze data on nonconforming products.
• Lead investigations on product failures.
• Manage complaint handling activities.

Skills

Flowcharts

Statistical data analysis

Mathematical reasoning

Problem-solving

Communication skills

CAPA experience

Education

Bachelor’s Degree in Technical and Scientific disciplines

Job description

LivaNova PLC is seeking a Quality Engineer in Arvada, CO to ensure compliance with quality management systems in medical device manufacturing. The role involves analyzing nonconforming products, leading investigations, and enhancing production quality.

Qualified candidates should have a Bachelor's degree and experience in medical devices. Benefits include health insurance, a 401K plan, and flexible work schedules.